MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05830-LWS

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For related complaint involving the same patient and event see mdr #3010532612-2019-00190 and (b)(4).

Event Description

It was reported that when the intra-aortic balloon (iab) ruptured a new iab was used.The second iab lasted a little longer but the second iab ruptured in a heavy calcified aorta.The hospital discontinued the pump and are transferring the patient.There was no report of patient injury or consequence.

Event Description

It was reported that when the intra-aortic balloon (iab) ruptured a new iab was used.The second iab lasted a little longer but the second iab ruptured in a heavy calcified aorta.The hospital discontinued the pump and are transferring the patient.There was no report of patient injury or consequence.

Manufacturer Narrative

(b)(4).For related complaint involving the same patient and event see mdr #3010532612-2019-00190 and tc #(b)(4).Teleflex received the device for investigation.The reported complaint of blood in helium pathway is confirmed.Punctures to the bladder, consistent with contact from the broken fiber, were found near the distal tip of the iab which allowed blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause of the broken fiber is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Additionally, the returned iab bladder was found withdrawn through the teflon sheath.The ifu states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." an in-service will be performed to reiterate the instructions for use (ifu) to the customer.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8717617
• MDR Text Key: 149186087
• Report Number: 3010532612-2019-00189
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F18L0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1